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Could less protamine be safer for heart surgery patients?

NCT ID NCT07477977

Disease control Sponsor: Sohag University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving a lower dose of protamine (a drug that reverses the blood thinner heparin) after heart-lung bypass is safe and effective. About 195 adults having elective heart surgery will be randomly assigned to one of three protamine doses. The goal is to see if lower doses still work well while causing fewer side effects like bleeding or blood pressure problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
protamine sulfate
What this could lead to
If successful, this could lead to safer heart surgery with fewer side effects from protamine, like bleeding or unstable blood pressure.
What could go wrong
This is a small, early-phase trial, so results may not apply to all patients. Lower doses might not fully reverse heparin, raising bleeding risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 195 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years * Patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CABG, valve surgery, or combined procedures) * Patients receiving systemic heparinization according to the institutional cardiopulmonary bypass protocol * Ability to provide written informed consent before surgery Exclusion Criteria: * Known allergy or hypersensitivity to protamine * Pre-existing coagulopathy or bleeding disorders * Patients receiving chronic anticoagulation that cannot be safely discontinued before surgery * Severe renal dysfunction * Severe hepatic dysfunction * Emergency cardiac surgery * Pregnancy * Off-pump cardiac surgery

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Conditions

The condition(s) this trial relates to.

Postoperative Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Open heart surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sohag University Hospital

    RECRUITING

    Sohag, Egypt

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